Recruiting

Knee Immobilization

Sponsor:

Hospital for Special Surgery, New York

Code:

NCT07552415

Conditions

Aseptic Revision Knee Arthroplasty

Stiffness Following Revision Knee Arthroplasty

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Knee immobilizer

No Knee Immobilizer

Study Details

Brief summary:

The goal of this study is to evaluate if knee immobilization for 10 days following revision total knee arthroplasty (rTKA) improves knee joint range of motion at 3 months postoperatively compared to standard of care postoperative protocol.

Participants will be assigned to one of two groups.

One group will wear a knee brace that keeps the knee straight for 10 days after surgery and will not perform knee range of motion exercises during that time. The other group will not wear a brace and will follow the standard physical therapy program, including knee range of motion exercises, starting after surgery.

Conditions

Aseptic Revision Knee Arthroplasty

Stiffness Following Revision Knee Arthroplasty

Study ID

NCT07552415

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients undergoing revision TKA for aseptic indications including aseptic loosening, polyethylene wear, instability, malalignment, periprosthetic fracture.
  • Patients undergoing revision TKA of one or both components.

Exclusion Criteria:

  • Patients who are undergoing revision TKA for stiffness.
  • Patients with occult infection not recognized prior to revision.
  • Patients with hinged TKA component reconstructions.
  • Patients undergoing revision for liner exchange.
  • History of VTE/PE.
  • Patients on pre-operative anticoagulation.
  • BMI ≥ 40.
  • Patients with preoperative opioid use equal to or exceeding 150 Morphine Milligram Equivalents (MMEs)/day within 90 days of revision TKA.

Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Study Group

Participants will wear a knee immobilizer brace for 10 days postoperatively and exclude knee range of motion exercises from postoperative physical therapy protocol during this period. They will resume all standard postoperative protocol after this period.

placebo comparator: Control Group

Participants will not wear a knee immobilizer and will perform all exercises included in postoperative physical therapy protocol.

Interventions

Knee immobilizer

Participants will wear a knee immobilizer brace for 10 days postoperatively and exclude knee range of motion exercises from postoperative physical therapy protocol during this period. They will resume all standard postoperative protocol after this period.

No Knee Immobilizer

Participants will not wear a knee immobilizer and will perform all exercises included in postoperative physical therapy protocol.

Primary outcome measure

  • Range of motion (degrees) - knee joint; measured using digital goniometer [ Time Frame: 3 months postoperatively ]

Central Contacts and Locations

Locations

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

Contacts

Dr. Brian P. Chalmers MD

212-606-1999chalmersb@hss.edu

Allina Nocon, PhD

646-714-6015nocona@hss.edu

More Information

Sponsor

Hospital for Special Surgery, New York

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • revision arthroplasty
  • stiffness
  • knee swelling

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hospital for Special Surgery, New York on 2026-08-24.